Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

JRCT ID: jRCT2080224547

Registered date:04/02/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Hyperkalemia
• Date of first enrollment: 28/02/2019
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Patiromer
INN of investigational material : ZG-801
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigational material : Starting dose: 1 or 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Starting dose: 1 or 2 packets/day, orally, once daily. The dose of placebo could be titrated based on subject's serum potassium response

Outcome(s)

Primary Outcome

efficacy
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose

Secondary Outcome

efficacy
Change in serum potassium 4 weeks after the start of administration in each group of starting dose
efficacy
Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each
group of starting dose
safety
Incidence of adverse events
safety
Incidence of adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Informed consent given
- Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Nondialysis patients) or 5.5 to < 6.5 mEq/L (Dialysis patients)

Exclude criteria

- Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
- Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
- Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
- Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
- Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
- Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
- Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
- Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT03799926,JapicCTI-194616